/Type /Catalog I was rather startled at how wrapped up I was. Study record managers: refer to the Data Element Definitions if submitting registration or results information. % I have one new for sale. /Contents [40 0 R 41 0 R 42 0 R 43 0 R 44 0 R 45 0 R 46 0 R 47 0 R] The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. Flexitouch Plus is the only FDA cleared pneumatic compression device for head and neck cancer-related lymphedema and can be prescribed during routine follow up care. /Parent 2 0 R A healthy lymphatic system moves lymph fluid throughout the body. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) Dr. Arturo Gonzalez and Dr. Alton R. Johnson, Cathy Thomas Hess, BSN, RN, CWOCN and Dr. Lisa Gould, MD, PhD, FACS, IC-1200-WH Vascu-Ease Portable DVT System, Recommendations for Wounds After Flaps and Grafts, How to Leverage Technology to Improve Patient Education and Outreach, From Chronic to Closure: An Innovative Approach to Manage Challenging Wounds, Working Smarter, Not Harder: Strategies for Wound Management Success, How to Advance Complex Wounds Toward Healing, Implementing Wound Hygiene: A Stepwise Approach, Uncommon Wounds: Frostbite and Winter Woes, What Clinicians Should Know About Comorbidities and Complex Wounds. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. Lymphatic drainage via pneumatic compression, Flexitouch Plus is the only FDA cleared pneumatic, compression device for head and neck cancer-related lymphedema and can be prescribed. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. Explain the situation to them. << >> endobj I can no longer Drive, go to the grocery store, take my kids for a walk or go to the park or anywhere for that matter. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! Lymphat Res Biol. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. /CropBox [0.0 0.0 612.0 792.0] Percentage of each response captured. /MediaBox [0.0 0.0 612.0 792.0] An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with Hi Karyn, I will post your comment and see if Sarah still has the pump available. Last updated March 2021. Hi Jaime, Im hopeful that your new pump will provide relief. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. It seems a lot of pumps are preprogrammed for the individual. Managing my lymphedema requires attention and an assortment of tools. /StructParents 0 UGH! Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed Outcome Measures Go to Primary Outcome Measures : Symptom/Problem Improvement From Baseline to 6 Months [ Time Frame: Percent Changes between Baseline and 6 months will be assessed ] 2016;14(4):198205. It delivers a noninvasive therapy that patients can administer themselves at home. So for almost every night for the next seven years I sat down and performed MLD on my left arm. If you dont mind, would you be willing to tell me what insurance company you have because it sounds like they were willing to help you? /Im0 24 0 R My go to place when I need calming. 17 0 obj 14 0 obj D/N500187-000-00 Rev. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). Toll-free: 1.833.3TACTILE (1.833.382.2845) (6Kjw_XGz'g &p The trial will compare the short- and long-term effectiveness of Tactile Medicals Flexitouch Plus system to usual care, such as complete decongestive therapy (CDT), for the management of lymphedema and fibrosis in head and neck cancer survivors. 13 0 obj /MediaBox [0.0 0.0 612.0 792.0] /Group << I got my Flexibtouch plus system last week that I was never measured for so the whole system feels to big on me, Ive had to call customer service several times because I cant get it to run correctly, They have it set up on 104 min. 3701 Wayzata Blvd, Suite 300 The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. I am on a fixed income and have to pay almost 1K for something that Tactile Medical SHOULD have measured fortheyre the experts and SHOULD have measured correctly. [Patient Registry], A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema, 18 Years and older (Adult, Older Adult), West Des Moines, Iowa, United States, 50265, Asheville, North Carolina, United States, 28805, Pittsburgh, Pennsylvania, United States, 15212. The woman from Idaho said her arm was softer and found the machine easy to use. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. The trial will compare the short- and long-term effectiveness of Tactile Medicals Flexitouch Plus system to usual care, such as complete decongestive therapy (CDT), for the management of lymphedema and fibrosis in head and neck cancer survivors. I have lymphedema in my right arm, breast and axilla. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. >>
It takes just 32 minutes per day. Surprisingly, my therapists measurements showed minimal difference with previous measurements. The head garment and vest for head and neck for the Flexitouch Plus system should not be used on patients who have one or more of the following conditions: Pneumatic compressor, segmental home model with calibrated gradient pressure, Chronic Venous Insufficiency Ridner, S.H., Dietrich, M.S., Deng, J. et al. Negative value shows a increase in quality of life. I am looking for the leg and trunk model is that what you have? The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. Sign up today for your free Reader Account. * American Society of Clinical Oncology 1. /Contents 75 0 R Call us at 1.833.3TACTILE (1-833-382-2845), 7:00 a.m. to 7:00 p.m. CT, Monday through Friday and 8:00 a.m. to 12:00 p.m. CT, Saturday. The head and neck garment set is easy to use and features the clinically proven Flexitouch technology that tens of thousands of lymphedema patients rely on every day to effectively treat their extremities. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with the Flexitouch Plus device. Oral Oncology. So we appealed 3 times. September 30, 2021 09:03 ET
In conducting this rigorous clinical trial, we hope to build on the initial body of evidence by evaluating the effectiveness of Flexitouch Plus in comparison to usual care, using a variety of measures to assess the benefits of this at-home treatment for patient health and quality of life.. /Type /Page /TT2 58 0 R
Its brand new, used 1 time. Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. >> Hi Kathi, The FaceTime call might work! While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. did you sell it yet? If you still have the system, I am interested. Except for my wrist, all my measurements showed reduction. For general information, Learn About Clinical Studies. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. They only measured the circumference of my thighs and calfskin, not the length, so now I am STUCK with a non-refundable almost 9K system that is too long for me. >> There is more to the whole story but bottom line is if you have this machine it changes everything they think they know about lymphedema! To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. . /C2_0 38 0 R The Flexitouch Plus system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema. When she said piano I froze. Important Notice: The contents of the website such as text, graphics, images, and other materials contained on the website ("Content") are for informational purposes only. << I cant explain that but I can visually see a difference. I?m 5? endobj endobj >> endobj Pembrolizumab plus cetuximab in patients with recurrent . /F 4 The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. Adams, KE, Rasmussen JC, Darne C, et al. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional
trunk and full leg, The legs dont inflate until the last 15 minutes of the cycle, and then the pressure is very weak in all of it, I can barely fill it, Its not nothing like the one I experienced at the dr office.. Your email address will not be published. My lymphedema therapist also told me that the pumps werent worth it. >> It was up to me to piece it together. /Rotate 0 << The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. The Flexitouch Plus system applies mild, dynamic pressure to stimulate lymphatic function and direct fluid away from impaired areas toward healthy, functioning regions where the fluid can be managed. /S /Transparency 46(4): 480487. They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. 12 0 obj 3 total ratings, 2 with reviews There was a problem filtering reviews right now. endobj Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). << /Tabs /S I use it every evening. I have a uniboot compressions on both of my calves. endobj Many head and neck cancer survivors are faced with an additional challenge: lymphedema. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. The whole process, though limiting my ambulation, was comfortable and relaxing. 11 0 obj The Companys unique offering includes advanced, clinically proven pneumatic compression devices, as well as continuity of care services provided by a national network of product specialists and trainers, reimbursement experts, patient advocates and clinicians. I didnt need a lymphedema physical therapist but too much to explain here. I always start with the one hour full arm and core setting. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? Everything in my life that I do and love and I am passionate about invloves using my hands and arms. HTn0+xIt XLRIiE)k!SS14U
E
__Z2om[]n&x*nAa(0A\0 /CropBox [0 0 612 792] Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. Tens of thousands of. endstream 5. << Tens of thousands of. For general information, Learn About Clinical Studies. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. << 2008-2023 HMP Global, Inc. All rights reserved. /Type /Page Phone: 1.612.355.5100 Required fields are marked *. Pain will be assessed using the VAS Pain Scale. 35 0 R] >> Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or product usage. I have a co/ pay of $422.57 yet to pay, But not until they get it so it can be used I kind of wish I had never got it. Most significantly was the reduction in my forearm. Toll-free: 1.833.3TACTILE (1.833.382.2845) My husband has a brand new system that Im trying to sell. endobj 1 0 obj The leg garments that I received are for a much taller person. Many, many of my patients love their pump. /A << /Contents 53 0 R The content is not intended to substitute manufacturer instructions. /Parent 2 0 R I have lymphedema near globally at this point and am trying to obtain coverage via insurance. >> Of the patients who tried the device, 88% saw a reduction in head and neck swelling after an initial 32-minute at-home treatment with the Flexitouch system, and 89% of patients reported. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. Both Ease of Use/Satisfaction will be assessed by survey. For more information, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/, Tactile Medical is a leader in developing and marketing at-home therapy devices that treat chronic swelling conditions such as lymphedema and chronic venous insufficiency. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. Talk with your doctor and family members or friends about deciding to join a study. 2015;151(11):11871193. I feel like my physical therapist or the sales rep from Tactile Medical should have caught this BEFORE I was encouraged to order an expensive machine that I may or may not be able to use. Since using the Flexitouch for almost a year, she had not experienced cellulitis. Filter by. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. K-ZB: HTo0~G6)BjH7u >> Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. I have been having weekly physical therapy to help with lymphedema and range of motion issues. For the year ended December 31, 2022, we generated revenue of $246.8 million and had a net loss of $17.9 million, compared to revenue of $208.1 million and a net loss of $11.8 million for the year . stream
Flexitouch Pd32-u Lymphedema Treatment System Pump. I did send them an email and asked them to look at your case again. As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. It takes just 32 minutes per day. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. >> >> I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. 14(4): p. 198-205. /CS /DeviceRGB /CropBox [0.0 0.0 612.0 792.0] XJ 2. My interest in pumps suddenly skyrocketed! | Source:
/Annots [10 0 R 11 0 R 12 0 R] Non-cancer related lymphedema patients demonstrated a: 75% decline in the rate of cellulitis, a 40% reduction in the rate of out-patient hospital visits, a 34% reduction in rate of physical therapy visits, and a 36% reduction in lymphedema-related costs. /MediaBox [0.0 0.0 612.0 792.0] << Muluk SC, Hirsch AT, Tafe EC. Another set of pads enveloped my left thigh and trunk. >> >> endobj /MediaBox [0 0 612 792] In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. 14(4): p. 198-205, 2. ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN 7 0 obj Subject Quality of Life will be assessed using EORTC C30 questionnaire. Head and Neck Lymphedema Treatment Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/. We rely on the generosity of individuals and sponsors who support our mission and activities. I wish you success! H]O0+=) ES You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. /TT1 70 0 R /Annots [25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. Biomedical Optics Express. /TT3 72 0 R Im only 44 years old , and I have kids that need mom back. /C2_1 55 0 R I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. 7:00 a.m. to 7:00 p.m. CT, Monday through Friday and 8:00 a.m. to 12:00 p.m. CT, Saturday, 3701 Wayzata Blvd, Suite 300 Toll-free: 1.833.3TACTILE (1.833.382.2845) Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. Hi Wandalynn . Thank you for sharing your husbands success with a pump. The pump is called the Flexitouch System by Tactile Medical. Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment, Device: Flexitouch system with Head and Neck Garments. Write a review. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. They will reach out to Flexitouch in the process of creating a segment for the news. /Subtype /Link /Contents 73 0 R Percent change is calculated by the difference between scores averaged at 6 months versus baseline. stream
Tactile Systems Technology, Inc. MINNEAPOLIS, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (Tactile Medical) (Nasdaq: TCMD), a medical technology company focused on developing medical devices for the treatment of chronic diseases at home, today announced the enrollment of the first patient in a randomized, controlled clinical trial evaluating the effectiveness of its Flexitouch Plus system for the treatment of head and neck lymphedema. Tactile Systems Technology (TCMD +0.6%) announces the enrollment of the first patient in a randomized, controlled trial evaluating the effectiveness of its Flexitouch Plus system for the treatment . See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use Swelling will be assessed using the ALOHA measurement protocol. Hi Kristie, Thank you for sharing your story. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. 15 0 obj No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. Lymphat Res Biol. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. All stars. Reading or watching TV are the activities Im able to do while Im being treated. Minneapolis, MN 55416 USA Flexitouch Plus is an advanced intermittent pneumatic compression device (lymphedema pump) that gives patients a comfortable and convenient way to self-manage lymphedema and non-healing venous leg ulcers. >> /Rotate 0 I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. It delivers a noninvasive therapy that patients can administer themselves at home. O ce they are used the government wont always them to use them on another. The pump has helped you achieve significant results. >> Words like new kind of pump, different than the old types, favorable studies, and Dr. 4? /TT2 71 0 R /CS /DeviceRGB I really need this system and had such desperate hope. >> Muluk SC, Hirsch AT, Tafe EC. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. You have reached the maximum number of saved studies (100). I subsequently found out that Flexitouch had actually been around for several years but a new study had brought awareness to this pneumatic compression device or lymphedema pump.